Section XVI:

FDA - Regulated Products

WPP #: XVI-6

Title 6:

Review of Drugs - IND Requirements (Investigational New Drug Application)

Effective Date:

2-5-07

Revision History:

06-07-04; 06-21-06

Objective

To describe the determination of need for an Investigational New Drug Application (IND) and to describe IND requirements to principal investigators who are or plan to be engaged in non-industry-sponsored, FDA-regulated, research.

Description

If the IRB determines that the study does not require an IND and approves the study, the study may begin without submission of an IND application to FDA. If the IRB determines that an IND is needed, the investigator/sponsor must submit an IND application to the FDA and provide documentation of the outcome of the FDA determination to the IRB before the IRB approves the study.

  1. Unique Additional Primary Reviewer Considerations:
    • It is the responsibility of the primary reviewer to review all requirements within this policy prior to the IRB meeting and lead the initial discussion regarding the IND requirements.
    • It is the responsibility of the primary reviewer to ensure that a valid IND# has been issued by the FDA. Prior to approval of the research, the IRB must verify IND # and status information. A copy of an official letter from the FDA regarding the status of the IND (including the number) in the investigator-submitted materials would suffice. If an official letter is not available or in question, the primary reviewer can use the following reference link to initiate the verification process: IND/IDE FDA Contacts.
    • It is the responsibility of the primary reviewer to evaluate the adequacy of the investigator's plans for control of the investigational drug/biologic. The reviewer may require the use of the investigational drug pharmacy (as appropriate) and may require specific post-approval monitoring or other stipulations.
  2. IND Definition: IND means an investigational new drug application. For purposes of this part, "IND" is synonymous with "Notice of Claimed Investigational Exemption for a New Drug." Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms "investigational drug" and "investigational new drug" are deemed to be synonymous.

  3. Procedure:

    The VCU IRB will consider a study using a drug product that is lawfully marketed in the United States to be exempt from the requirements for obtaining an IND if all the following apply:

    1. The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug;
    2. If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product;
    3. The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;
    4. The investigation is conducted in compliance with the requirements for institutional review and with the requirements for informed consent; AND
    5. The investigation is conducted in compliance with the requirements with regard to promotion and charging for investigational drugs in 21CFR312.7
  4. Exemption:
    1. A clinical investigation involving an in vitro diagnostic biological product that is a blood grouping serum, reagent red blood cells, or anti-human globulin is exempt from the requirements for an IND if:
      1. It is intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure;

        AND

      2. It is shipped in compliance with 21CFR312.160.
    2. A drug intended solely for tests in vitro is exempt from the requirements of an IND if it is shipped in accordance with 21CFR312.160.
    3. A clinical investigation involving use of a placebo is exempt from the requirements of an IND if the investigation does not otherwise require submission of an IND.

Responsibility

It is ultimately the responsibility of the principal investigator to ensure that IND requirements under 21 CFR 312 are met. Verification of the IND prior to IRB approval is the responsibility of the primary reviewer.

References

21 CFR 312
IND/IDE FDA Contacts